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Phase II Evaluation of AHCC for the Eradication of HPV Infections (AHCC4HPV)

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ClinicalTrials.gov Identifier: NCT02405533
Recruitment Status : Active, not recruiting
First Posted : April 1, 2015
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Judith A. Smith, The University of Texas Health Science Center, Houston

Brief Summary:
This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary outcome of this trial is achieving durable eradication persistent high risk HPV infection determined by HPV negative test results achieved while on active treatment with AHCC and maintained for 6 month post supplementation and 12 months post completion of AHCC treatment compared to placebo.

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Dysplasia CIN1 CIN2 Dietary Supplement: AHCC 3 grams once a day Other: Placebo Not Applicable

Detailed Description:
This is a phase II randomized, double-blind placebo-controlled, crossover trial. The primary outcome of this trial is achieving durable eradication HPV infection determined by HPV negative test results achieved while on active treatment with AHCC and maintained for 6 month post supplementation and 12 months post completion of AHCC treatment for Group 1. We will follow all patients for at least 12 months and up to 30 months depending on success of achieving a negative HPV testing results. After receiving AHCC 3 grams x 6 months if positive at the end of 12 months of study treatment, they are considered a treatment failure. If negative after completion of 6 months of AHCC supplementation + 6 months of placebo, they will continue on study for another six months (2 visits) to confirm they remain HPV negative and durable response. Group 2 will serve as untreated control for all time points (end of supplementation, then 6, 9, and 12 months post end of AHCC supplementation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo control phase II study that patients receive either AHCC or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-blind, Placebo-controlled Evaluation of AHCC (Active Hexose Correlated Compound) for the Eradication of HPV Infections in Women With HPV Positive Pap Smears
Actual Study Start Date : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Group 1
AHCC 3 grams once a day on an empty stomach x 6 months then placebo once a day x 56 months.
Dietary Supplement: AHCC 3 grams once a day
AHCC supplementation x 6 months with Placebo x 6 months
Other Name: active hexose correlated compound

Placebo Comparator: Group 2
Placebo once a day on an empty stomach x 12 months
Other: Placebo
Placebo supplementation x 12 months




Primary Outcome Measures :
  1. Roche, COBAS HPV DNA Assay (Pleasanton, CA) [ Time Frame: once every 3 months for 12 months up to 18 months ]
    HPV DNA testing


Secondary Outcome Measures :
  1. Interferon beta [ Time Frame: once every 3 months for 12 months up to 18 months ]
    Evaluation of Interferon Beta level

  2. Interferon gamma [ Time Frame: once every 3 months for 12 months up to 18 months ]
    Evaluation of Interferon gamma level

  3. NK Cells [ Time Frame: once every 3 months for 12 months up to 18 months ]
    Evaluation of Natural Killer (NK) cells



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Women over 30 years of age who have a HPV positive test and normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia within three months of study entry.

    • Women must have had 2 other HPV positive tests with normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia

      • 1 greater than 6 months and no more than 18 months prior to study entry
      • 1 greater than 24 months prior to study entry.
    • Women of child bearing potential must have a negative urine pregnancy test within 7 days of therapy start.
    • Patients must have adequate hematologic, renal, and hepatic function as noted from labs within the previous 12 months: ANC >/= 1,500 cells/mm3, platelets 100,000 >/= cells/mm3; Creatinine clearance>/= 60 mL/min (estimated by Cockcroft Gault equation), total bilirubin, SGPT, SGOT, and alkaline phosphatase </= 1.5 times normal.
    • Patients of child-bearing age must agree to use effective methods of contraception (oral contraceptives, condoms, etc.) while on study.

Exclusion Criteria:

  • • History of myocardial infarction within past 6 months, unstable angina, CHF, or uncontrolled hypertension (> 140/90).

    • Women with a current or prior diagnosis of cancer
    • Women with a current diagnosis of CIN3 cervical dysplasia
    • Women that are pregnant or breast feeding.
    • Women with a history of Hepatitis (autoimmune, A, B, or C) or antigen positive
    • Patients with history of significant psychiatric disorders (schizophrenia, bipolar, psychosis) or uncontrolled seizures.
    • Patients with significant medical co-morbidities at the discretion of the primary Gynecologist. Including immunosuppressive conditions (i.e. HIV+, rheumatoid arthritis, etc) or taking immune modulation mediations (i.e. immunosuppressants)
    • Women that have taken AHCC within the past six months.
    • Women currently taking other immune modulating nutritional supplements.
    • Patients who have undergone a hysterectomy (supracervical hysterectomy allowed)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405533


Locations
United States, Texas
UTHealth Medical School at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Study Chair: Judith A Smith, Pharm.D. UTTexas_Houston

Responsible Party: Judith A. Smith, Associate Professor & Director of WHIM Research Program, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02405533     History of Changes
Other Study ID Numbers: HSC-MS-14_0866
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Judith A. Smith, The University of Texas Health Science Center, Houston:
AHCC
nutritional supplement
HPV

Additional relevant MeSH terms:
Papilloma
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Virus Diseases
Tumor Virus Infections